MELOXICAM PENSA 15 mg TABLETS

Introduction

Package Leaflet: Information for the User

Meloxicam Pensa 15 mg Tablets EFG

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

if they have the same symptoms as you.

• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Meloxicam Pensa and what is it used for
2. What you need to know before you take Meloxicam Pensa
3. How to take Meloxicam Pensa
4. Possible side effects
5. Storage of Meloxicam Pensa
6. Contents of the pack and other information

1. What is Meloxicam Pensa and what is it used for

Meloxicam belongs to a group of medicines called non-steroidal anti-inflammatory drugs (NSAIDs) used to reduce inflammation and pain in joints and muscles.

Meloxicam is indicated in adults and children over 16 years of age.

Meloxicam is used for:

• short-term treatment of osteoarthritis flare-ups
• long-term treatment of:

• rheumatoid arthritis
• ankylosing spondylitis.

2. What you need to know before you take Meloxicam Pensa

Do not take Meloxicam Pensa if:

• you are allergic to meloxicam or any of the other ingredients of this medicine (listed in section 6)
• during the last three months of pregnancy
• children and adolescents under 16 years of age
• wheezing (bronchospasm), chest tightness, shortness of breath (asthma)
• nasal polyps
• skin rash/urticaria
• sudden inflammation of the skin or mucous membranes such as inflammation around the eyes, face, lips, mouth or throat, which may cause difficulty breathing (angioedema)
• • stomach or intestinal bleeding
  • holes (perforations) in your stomach or intestine

• stomach or intestinal ulcers or bleeding
• severe liver function impairment
• severe non-dialysed renal failure
• recent cerebral bleeding (cerebrovascular haemorrhage)
• any type of bleeding disorder
• severe heart failure
• intolerance to some sugars, as this medicine contains lactose (see also “Meloxicam Pensa contains lactose”)

If you are not sure about any of the above, please contact your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to take Meloxicam Pensa.

Warnings

Medicines like Meloxicam Pensa may be associated with a slightly increased risk of heart attack (“myocardial infarction”) or stroke (“cerebral infarction”). Any risk is greater at high doses and in prolonged treatments. Do not take more than the recommended dose. Do not take Meloxicam Pensa for longer than you have been prescribed (see section 3 “How to take Meloxicam Pensa”).

If you have heart problems, previous stroke or if you think you may be at risk of suffering from any of these diseases, you should discuss the treatment with your doctor or pharmacist. For example, if you:

• have high blood pressure (hypertension)
• have high blood sugar levels (diabetes mellitus)
• have high cholesterol levels (hypercholesterolemia)
• are a smoker

Stop your treatment with Meloxicam Pensa immediately as soon as you notice bleeding (which causes black stools) or ulcers in your digestive system (causing abdominal pain).

Life-threatening skin rashes have been reported with the use of Meloxicam Pensa, initially appearing as red circular patches, often with a central blister.

Other additional signs that may appear are sores in the mouth, throat, nose, genitals and conjunctivitis (swollen and red eyes).

These life-threatening skin rashes are often accompanied by flu-like symptoms. The rash may progress to form widespread blisters or peeling of the skin.

The period of highest risk for the onset of serious skin reactions is during the first weeks of treatment.

If you have developed Stevens-Johnson syndrome or toxic epidermal necrolysis with the use of Meloxicam Pensa, you should not use Meloxicam Pensa again at any time. If you develop a rash or these skin symptoms, stop taking Meloxicam Pensa and go immediately to a doctor and inform them that you are taking this medicine.

Meloxicam Pensa is not suitable if you need to relieve acute pain immediately.

Meloxicam Pensa may mask the symptoms of an infection (e.g. fever). If you think you may have an infection, you should see a doctor.

If you have ever experienced a fixed drug eruption (rounded or oval patches with redness and swelling of the skin that usually recur in the same place, blistering, urticaria and itching) after taking meloxicam or other oxicams (e.g. piroxicam).

Precautions for use

As it will be necessary to adjust the treatment, it is important to ask your doctor for advice before taking Meloxicam Pensa in case of:

• having suffered from inflammation of the throat (oesophagitis), stomach inflammation (gastritis) or a history of any other digestive system disease, e.g. Crohn's disease, ulcerative colitis
• high blood pressure (hypertension)
• advanced age
• heart, liver or kidney disease
• high blood sugar levels (diabetes mellitus)
• reduced blood volume (hypovolemia) that may occur if you have suffered significant blood loss or severe burns, surgery or low fluid intake
• intolerance to certain sugars diagnosed by your doctor, as this medicine contains lactose
• high potassium levels in the blood previously diagnosed by your doctor. Your doctor will need to monitor your progress during treatment.

Taking Meloxicam Pensa with other medicines

As Meloxicam Pensa may affect or be affected by other medicines, inform your doctor or pharmacist if you are taking, have taken or might take any other medicines.

In particular, please inform your doctor or pharmacist if you are taking/ have taken or have used any of the following medicines:

• other NSAIDs
• potassium salts (used to prevent or treat low potassium levels in the blood)

• tacrolimus (used after organ transplantation)
• • trimethoprim used in the treatment of urinary tract infections
  • medicines that prevent blood clotting
  • medicines that dissolve blood clots (thrombolytics)
  • medicines for treating heart and kidney diseases
  • corticosteroids (e.g. used in inflammation or allergic reactions
  • cyclosporin used after organ transplantation or for severe skin diseases, rheumatoid arthritis or nephrotic syndrome)

• deferasirox (used to treat chronic iron overload caused by frequent blood transfusions)
• • any diuretic medicine (“water tablets”). Your doctor may monitor your kidney function if you are taking diuretics
  • medicines for treating high blood pressure (e.g. beta-blockers
  • lithium used to treat behavioural disorders)
  • selective serotonin reuptake inhibitors (SSRIs) (used to treat depression)
  • methotrexate used to treat tumours or severe uncontrolled skin diseases or active rheumatoid arthritis)
  • pemetrexed (used in the treatment of cancer)
  • colestyramine used to reduce cholesterol levels)
  • oral antidiabetics (sulphonylureas, nateglinide) (used to treat diabetes. Your doctor should carefully monitor your blood sugar levels for hypoglycaemia)

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

During the first and second trimester of pregnancy, your doctor will only prescribe this medicine if it is clearly necessary due to the potential risk of abortion or malformation. In this case, the dose should be kept as low as possible and the duration of treatment should be as short as possible.

During the last three months of pregnancy, this medicine is contraindicated: NEVER take this medicine because it may have serious or even fatal consequences for your foetus/child. It may cause kidney and heart problems for your foetus. It may affect your tendency and that of your baby to bleed and delay or prolong labour more than expected. From the 20th week of pregnancy, meloxicam may cause kidney problems for your foetus if taken for more than a few days, which may cause low levels of the fluid that surrounds the baby (oligohydramnios). If you need treatment for more than a few days, your doctor may recommend additional monitoring.

If you have taken this medicine while pregnant, you should talk to your doctor/midwife immediately so that adequate monitoring can be considered.

Breast-feeding

This medicine is not recommended during breast-feeding.

Fertility

This medicine may make it more difficult for you to become pregnant. You should inform your doctor if you are planning to become pregnant or if you have problems becoming pregnant.

Driving and using machines

This medicine may cause changes in vision including blurred vision, dizziness, drowsiness, vertigo or other changes in the central nervous system. If you notice these effects, do not drive or use machines.

Meloxicam Pensa contains lactose

This medicine contains lactose. If your doctor has told you that you have an intolerance to some sugars, contact them before taking this medicine.

This medicine contains less than 23 mg of sodium (1 mmol) per tablet; this is essentially “sodium-free”.

3. How to take Meloxicam Pensa

Follow exactly the instructions of administration of this medicine given to you by your doctor. In case of doubt, consult your doctor or pharmacist again.

The recommended dose is

Osteoarthritis flare-ups:

7.5 mg (half a tablet) once a day. This can be increased to 15 mg (one tablet) once a day.

Rheumatoid arthritis:

15 mg (one tablet) once a day. This can be reduced to 7.5 mg (half a tablet) once a day.

Ankylosing spondylitis:

15 mg (one tablet) once a day. This can be reduced to 7.5 mg (half a tablet) once a day.

Do not exceed the maximum recommended dose of 15 mg per day.

If any of the situations described under the heading “Warnings and precautions” apply to you, your doctor may limit your dose to 7.5 mg (half a tablet) once a day.

Elderly patients

If you are an elderly person, the recommended dose in long-term treatment for rheumatoid arthritis and ankylosing spondylitis is 7.5 mg (half a tablet) once a day.

Patients at increased risk of adverse reactions

If you are a patient at increased risk of adverse reactions, your doctor will start treatment at a dose of 7.5 mg (half a tablet) per day.

Renal impairment

If you are a patient on dialysis with severe renal impairment, your dose should not exceed 7.5 mg (half a tablet) per day. In patients with mild to moderate renal impairment, no dose reduction is necessary.

Hepatic impairment

In patients with mild to moderate hepatic impairment, no dose reduction is necessary.

Use in children and adolescents

Meloxicam should not be administered to children and adolescents under 16 years of age.

Consult your doctor or pharmacist if you think the action of meloxicam is too strong or too weak or if after several days you do not notice any improvement.

Method of administration

Oral use.

The tablets should be swallowed with water or another drink during a meal in a single intake per day.

If you take more Meloxicam Pensa than you should

If you have taken too many tablets or suspect an overdose, contact your doctor or go to the nearest hospital immediately.

The symptoms associated with acute NSAID overdoses are usually limited to:

• lack of energy (lethargy)
• drowsiness
• nausea and vomiting
• stomach pain (epigastric pain).

These symptoms usually improve when meloxicam is stopped. Gastrointestinal bleeding may occur.

Severe poisoning may cause serious adverse reactions (see section 4):

• high blood pressure (hypertension)
• acute kidney failure (renal failure)

• liver function disorders (liver failure)
• reduced or stopped breathing (respiratory depression)
• loss of consciousness (coma)
• seizures (convulsions)
• circulatory collapse (cardiovascular collapse)
• heart arrest (cardiac arrest)
• immediate allergic reactions (hypersensitivity), including:

• fainting
• shortness of breath

skin reactions

If you have taken more meloxicam than you should, consult your doctor or pharmacist immediately or call the Toxicology Information Service, telephone 91 562 04 20, indicating the medicine and the amount used. It is recommended to take the package and the package leaflet of the medicine to the healthcare professional.

If you forget to take Meloxicam Pensa

Do not take a double dose to make up for forgotten doses. Simply take the next dose at the usual time.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, this medicine can have adverse effects, although not all people suffer from them.

Stop taking Meloxicam Pensa and consult your doctor or the nearest hospital immediately if you notice:

Any allergic reaction (hypersensitivity) that may appear in the form of:

• skin reactions such as itching (pruritus), blistering of the skin or peeling, which can be life-threatening skin rashes (Stevens-Johnson syndrome and toxic epidermal necrolysis), soft tissue damage (mucosal lesions) or erythema multiforme (see section 2).

Erythema multiforme is a severe allergic skin reaction that causes spots, red patches or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.

• inflammation of the skin or mucous membranes such as inflammation around the eyes, face, and lips, mouth or throat, possibly making breathing difficult, swollen ankles/legs (edema of the lower limbs)
• difficulty breathing or asthma attacks
• liver inflammation (hepatitis). This can cause symptoms such as:

• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

Any adverse effect on the digestive system, especially:

• bleeding (causing black stools)
• ulcers in the digestive system (causing abdominal pain).

Gastrointestinal bleeding (gastrointestinal hemorrhage), the formation of ulcers, or a hole in the digestive system (perforation) can sometimes be severe and potentially life-threatening, especially in elderly people.

If you have previously suffered from any digestive system symptoms due to prolonged use of NSAIDs, seek medical advice immediately, especially if you are an elderly person. Your doctor may monitor your progress while you are being treated.

If you experience vision disturbances, do not drive or use machines.

General Adverse Effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The use of some non-steroidal anti-inflammatory drugs (NSAIDs) may be associated with a slight increase in the risk of arterial vascular occlusion (thrombotic arterial events), e.g., heart attack (myocardial infarction) or stroke (apoplexy), particularly at high doses and in long-term treatment.

Cases of fluid retention (edema), high blood pressure (hypertension), and heart failure (heart failure) associated with NSAID treatment have been reported.

The most commonly observed adverse reactions affect the digestive system (gastrointestinal events):

• stomach and upper small intestine ulcers (peptic/gastroduodenal ulcers)
• a hole in the intestine wall (perforation) or gastrointestinal bleeding (sometimes fatal, especially in elderly people)

After administration of NSAIDs, the following adverse reactions have been reported:

• nausea and vomiting
• diarrhea
• flatulence
• constipation
• indigestion (dyspepsia)
• abdominal pain
• black stools due to gastrointestinal bleeding (melena)
• vomiting blood (hematemesis)
• inflammation with ulcer formation in the mouth (ulcerative stomatitis)
• worsening of digestive tract inflammation (e.g., exacerbation of colitis or Crohn's disease)

Less frequently, stomach inflammation (gastritis) has been observed.

Adverse Effects of Meloxicam - Active Substance of Meloxicam Pensa

Very Common: may affect more than 1 in 10 people

• gastrointestinal adverse reactions such as indigestion (dyspepsia), nausea, and vomiting, abdominal pain, constipation, flatulence, diarrhea

Common: may affect up to 1 in 10 people

• headache

Uncommon: may affect up to 1 in 100 people

• dizziness (feeling of dizziness)
• feeling of dizziness or rotation (vertigo)
• drowsiness (somnolence)
• anemia (decrease in the amount of hemoglobin in red blood cells)
• increased blood pressure (hypertension)
• hot flashes (temporary redness in the face and neck)
• water and sodium retention
• increased potassium levels (hyperkalemia). This can cause symptoms such as:
• changes in heart rhythm (arrhythmias)
• palpitations (when you notice your heartbeats more than usual)
• muscle weakness
• belching
• stomach inflammation (gastritis)
• gastrointestinal bleeding
• mouth inflammation (stomatitis)
• immediate allergic reactions (hypersensitivity)
• itching (pruritus)
• skin reaction
• inflammation caused by fluid retention (edema), including swollen ankles/legs (edema of the lower limbs)
• sudden inflammation of the skin or mucous membranes, such as inflammation around the eyes, face, lips, mouth, or throat, possibly making breathing difficult (angioedema)
• transient changes in liver function values (e.g., increased liver enzyme levels such as transaminases or increased bilirubin). Your doctor may detect them by performing a blood test
• changes in kidney function laboratory tests (e.g., increased creatinine or urea)

Rare: may affect up to 1 in 1,000 people

• mood changes
• nightmares
• abnormal blood count, including:
• abnormal differential blood count
• decrease in the number of white blood cells (leucopenia)
• decrease in the number of platelets (thrombocytopenia)

These adverse effects can increase the risk of infection and cause symptoms such as bruising or nosebleeds.

• ringing in the ears (tinnitus)
• noticing heartbeats (palpitations)
• stomach or upper small intestine ulcers (peptic/gastroduodenal ulcers)
• throat inflammation (esophagitis)
• onset of asthma attacks (observed in people allergic to acetylsalicylic acid (aspirin) or other NSAIDs)
• severe blistering of the skin or peeling (Stevens-Johnson syndrome and toxic epidermal necrolysis)
• hives
• vision changes including:
• blurred vision
• conjunctivitis (inflammation of the eye or eyelid)
• inflammation of the large intestine (colitis)

Very Rare: may affect up to 1 in 10,000 people

• vesicular skin reactions (blistering) and redness (erythema) multiforme.
• Erythema multiforme is a severe allergic skin reaction that causes spots, red patches, or purple areas with blisters. It can also affect the mouth, eyes, and other moist areas of the body.
• liver inflammation (hepatitis). This can cause symptoms such as:

• yellowing of the skin and eyes (jaundice)
• abdominal pain
• loss of appetite

• acute kidney failure (renal failure) particularly in patients with risk factors such as heart disease, diabetes, or kidney disease.
• a hole in the intestine wall (perforation)

Frequency Not Known: frequency cannot be estimated from available data

• confusion
• disorientation
• shortness of breath and skin reactions (anaphylactic/anaphylactoid reactions) due to sun exposure (photosensitivity reactions)
• heart failure (heart failure) associated with NSAID treatment has been described
• complete loss of certain types of white blood cells (agranulocytosis), especially in patients taking Meloxicam Pensa with other drugs that can potentially inhibit, depress, or destroy a component of the bone marrow (myelotoxic drugs). This can cause:
• sudden fever
• sore throat
• infections
• pancreas inflammation (pancreatitis)

• infertility in women, delayed ovulation

• a characteristic skin allergic reaction known as fixed drug eruption, which usually reappears in the same location in case of re-exposure to the medication and can appear as rounded or oval plaques with redness and swelling of the skin, blistering (urticaria), and itching.

Adverse Effects Caused by Other Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) that Have Not Been Seen After Taking Meloxicam Pensa

Changes in kidney structure that cause acute kidney failure:

• very rare cases of kidney inflammation (interstitial nephritis)
• death of some kidney cells (acute tubular necrosis or papillary necrosis)
• proteins in the urine (nephrotic syndrome with proteinuria)

Reporting of Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Meloxicam Pensa

Keep this medicine out of the sight and reach of children.

No special storage conditions are required.

Do not use this medicine after the expiration date that appears on the blister pack and outer packaging. The expiration date is the last day of the month indicated.

Medicines should not be disposed of via wastewater or household waste. Deposit the packaging and medicines you no longer need at the SIGRE collection point in your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This will help protect the environment.

6. Package Contents and Additional Information

Composition of Meloxicam Pensa

The active substance is meloxicam. Each tablet contains 15 mg of meloxicam.

The other ingredients (excipients) are: sodium citrate, microcrystalline cellulose, lactose monohydrate, povidone, anhydrous colloidal silica, magnesium stearate, sodium carboxymethyl starch (type A).

Appearance of the Product and Package Contents

Yellow, cylindrical, biconvex, scored tablets marked with the code "M1" on one side.

Meloxicam Pensa 15 mg tablets are available in packs containing 20 tablets.

Marketing Authorization Holder

Towa Pharmaceutical, S.A.

C/ de Sant Martí, 75-97

08107 Martorelles (Barcelona)

Spain

Manufacturer

Laboratorios Cinfa, S.A. c/Olaz-Chipi, 10. 31620 Huarte- Pamplona

Date of Last Revision of this Leaflet: May 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS)

http://www.aemps.es/